|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Information provided by: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00652899 |
Purpose
RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's natural killer cells. Aldesleukin may stimulate the natural killer cells to kill ovarian, fallopian tube, or primary peritoneal cancer cells. Treating the donor natural killer cells with aldesleukin may help the natural killer cells kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving laboratory-treated donor natural killer cells together with aldesleukin works when given after cyclophosphamide, fludarabine, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: Allopurinol Drug: Cyclophosphamide Drug: Fludarabine phosphate Radiation: total-body irradiation Biological: Allogeneic natural killer cells Biological: Aldesleukin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer |
| Enrollment: | 14 |
| Study Start Date: | March 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Total Body Irradiation
This group includes patients that received all chemotherapy, infusion of natural killer (NK) cells and total body irradiation per protocol. 1. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m^2 on Days 6 through 2 preceding NK cell infusion. 4. Radiation: total-body irradiation 200 cGy Day 1 preceding NK cell infusion. 5. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 * 10^7/kg. 6. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0. |
Biological: Allopurinol
All patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion.
Other Name: Zyloprim
Drug: Cyclophosphamide
60 mg/m^2 on Days 4 and 5 preceding natural killer cell infusion.
Other Name: Cytoxan
Drug: Fludarabine phosphate
25 mg/m^2 on Days 6 through 2 preceding natural killer cell infusion.
Other Name: Fludarabine
Radiation: total-body irradiation
200 cGy Day 1 preceding natural killer cell infusion.
Other Name: TBI
Biological: Allogeneic natural killer cells
Given day 0 - dose of 1.5-8.0 * 10^7/kg
Other Name: related donor haploidentical allogenic cell infusion
Biological: Aldesleukin
10 MU 3 times/week for a total of 6 doses beginning Day 0
Other Names:
|
|
Experimental: No Total Body Irradiation
This group includes patients that received chemotherapy and infusion of natural killer cells, but did not receive total body irradiation. 1. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m^2 on Days 6 through 2 preceding NK cell infusion. 4. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 * 10^7/kg. 5. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0. |
Biological: Allopurinol
All patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion.
Other Name: Zyloprim
Drug: Cyclophosphamide
60 mg/m^2 on Days 4 and 5 preceding natural killer cell infusion.
Other Name: Cytoxan
Drug: Fludarabine phosphate
25 mg/m^2 on Days 6 through 2 preceding natural killer cell infusion.
Other Name: Fludarabine
Biological: Allogeneic natural killer cells
Given day 0 - dose of 1.5-8.0 * 10^7/kg
Other Name: related donor haploidentical allogenic cell infusion
Biological: Aldesleukin
10 MU 3 times/week for a total of 6 doses beginning Day 0
Other Names:
|
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE:
Patients achieving any initial response (complete or partial response) or a clinical benefit (stable disease for > 6 months) who progress after 6 months may receive 1 re-treatment course as above.
Blood samples are collected at baseline, on days 0, 7, 14, and 28, and then at 2 and 3 months post NK cell infusion for cytokine measurements, immunophenotyping, functional analyses, and testing for persistence of donor cells.
After completion of study treatment, patients are followed periodically for at least 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function as determined by the following criteria within 14 days of study enrollment:
Exclusion Criteria:
Human anti-mouse antibody (HAMA) monitoring: All subjects will be questioned about prior exposure to antibody therapy (including OKT3, Rituximab, Trastuzumab, etc). Responses will be recorded and reported to the FDA as part of the annual report. For subjects with no prior antibody therapy exposure, no further action will be taken. For subjects who have received previous antibody therapies 10 ml of serum (red top tube) will be drawn before starting therapy and banked per section 8.1. The presence of HAMA will not exclude a patient from the study.
Contacts and Locations| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Melissa A. Geller, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Melissa A. Geller, Masonic Cancer Center at University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00652899 History of Changes |
| Other Study ID Numbers: | 2007LS138, UMN-MT2007-19R, UMN-WCC-53, UMN-0712M23462 |
| Study First Received: | April 3, 2008 |
| Results First Received: | August 20, 2010 |
| Last Updated: | July 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor stage IV ovarian epithelial cancer |
stage IV ovarian germ cell tumor fallopian tube cancer peritoneal cavity cancer |
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Allopurinol Fludarabine monophosphate Vidarabine Cyclophosphamide Fludarabine Aldesleukin Interleukin-2 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents |